The editorial by Zachary T Bloomgarden at the Icahn School of Medicine, Mount Sinai, USA highlights that, since the early 1990s the use of insulin to treat diabetes has increased substantially, see Figure 1. 

Figure 1: UK insulin users and total annual insulin market value

There are now an estimated 37.7 million insulin-treated diabetes patients worldwide, see Figure 2.

Figure 2: Estimated current number of insulin users with T1D and with T2D, worldwide and the US

The first long-acting insulin analogue, insulin glargine, was approved in 2020, and Bloomgarden notes that there is evidence to suggest that treatment with analogues is preferable to biosynthetic human insulin (BHI) treatment. However, treatment with insulin analogues is expensive at almost US$6,000 per insulin-treated person annually in the US. He notes that it is suggested that the use and uptake of biosimilar insulins could reduce expenditures by 50%.

Bloomgarden also highlights that the US Food and Drug Administration (FDA) distinguishes between follow-on biologicals, that are ‘highly similar to the reference product notwithstanding minor differences in clinically inactive components,’ and having ‘no clinically meaningful differences from reference product in safety, purity, and potency’; and interchangeable biosimilars, that can be substituted for one another and the reference at the pharmacy level. He gives the details of various studies to demonstrate that a given dose of insulin has highly variable expected action, despite this, a variety of biosimilar insulin preparations show satisfactory results in diabetes treatment. 

Furthermore, the dosing device can play an important role in treatment and changing device can cause errors in dosing that cause more problems than changing medication.

In conclusion, there is ‘strong rationale for encouraging biosimilar insulin development and effectiveness of biosimilar insulin analogue preparations developed to date appears satisfactory. The concept of stressing interchangeability as a criterion may, however, not be as important clinically as has been thought by regulatory authorities, given the marked variation in day-to-day insulin action in persons treated with the products currently in use, and issues with different devices of supposedly interchangeable insulin preparations are quite likely to cause clinical issues’.
As long as attention is paid to potential safety issues with the products, biosimilar insulins can offer more affordable and effective treatment of diabetes, according to Bloomgarden.

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New and upcoming biosimilars launches in the US

US prescription drug expenditure projection report

United States legislation to improve access to insulin

Reference
1. Bloomgarden ZT. Biosimilar insulin concepts. J Diabetes. 2022;14(4):231-5.

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